Gastric SurgeryNCT07572058
Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System
A study testing Large Diameter ViSiGi LUX ™ in people with Gastric Surgery, run by Boehringer Labs LLC at 1 site in United States.
Trial summary
This study investigates the use of the large diameter ViSiGi LUX ™ Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Surgery
- What is being tested?
- Large Diameter ViSiGi LUX ™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Able to consent
- Candidate for laparoscopic gastric surgery
Who cannot join
- Esophageal stricture that does not allow passage of the device
- Conditions that would preclude gastric surgical procedures
- Pregnant patients
- Non-English-speaking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Eisenhower Medical Center
Rancho Mirage, California, 92270
Lainie Hughes, 760-837-8237, lhughes@eisenhowerhealth.org
About this study
Official title: Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System Usability Study
This study investigates the use of the large diameter ViSiGi LUX ™
- Conditions
- Gastric Surgery
- Being tested
- Large Diameter ViSiGi LUX ™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Diameter ViSiGi LUX ™Device
ViSiGi LUX ™ is used during numerous gastric procedures. This new device functions the same as ViSiGi LUX ™ but has an increased diameter representative of existing devices used more frequently in upper gastric procedures.
| Study group | Role | What they receive |
|---|---|---|
| Large Diameter ViSiGi LUX ™ | Experimental | Not described Receives: Device: Large Diameter ViSiGi LUX ™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Successful introduction of the sizing and calibration system, correct positioning and function intraoperatively will be logged following each use of the device. This will be assessed by the operating physician.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start19 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Labs LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572058
- Sponsor's protocol ID
- LDL-1
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System Usability Study
- ClinicalTrials.gov ID
- NCT07572058
- Acronym / sponsor ID
- LDL-1
- Conditions
- Gastric Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Boehringer Labs LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the use of the large diameter ViSiGi LUX ™
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Large Diameter ViSiGi LUX ™ | Experimental | Device: Large Diameter ViSiGi LUX ™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Able to consent
- Candidate for laparoscopic gastric surgery
Key exclusion criteria (4 listed)
- Esophageal stricture that does not allow passage of the device
- Conditions that would preclude gastric surgical procedures
- Pregnant patients
- Non-English-speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Large Diameter ViSiGi LUX ™ViSiGi LUX ™ is used during numerous gastric procedures. This new device functions the same as ViSiGi LUX ™ but has an increased diameter representative of existing devices used more frequently in upper gastric procedures. | Device | Large Diameter ViSiGi LUX ™ |
Primary outcome
Technical success rate
Time frame: 6 months
Successful introduction of the sizing and calibration system, correct positioning and function intraoperatively will be logged following each use of the device. This will be assessed by the operating physician.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large Diameter ViSiGi LUX ™ in people with Gastric Surgery, run by Boehringer Labs LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barrett Genovese (4849312294, bgenovese@boehringerlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.